ISO 28158-2010 pdf download.Dentistry – Integrated dental floss and handles.
4 Requirements
4.1 Matectal and shape
4.1.1 Matertal
Th. ntal lois and handl. shall b. fra. from .xlr.n.ous ma.r whn .xam.ned accordWig to 6.2 a), Matenals witent.onally added to dental floss handle, such as wax, p.gm.nqs or lbvounng agents. sh be considered as pert of the device
4.1.2 Shape
Tb. integrated d.nlal floss and han aid n hav. any sharp surface or parts wh.n .xavnired .ccordlng to
6.2 b), except when a part, .1 Included, Is designed and Intended to be used as a tonthpeck
4.2 Strength
The w*eaLed dental loss and handle slid wttha*and Vie stabc load of ION for 101 wIthout a breakage of lb. floes or han. and withaut a pull-out of lb. floss from 11w handle wh.n determined in accordance w*h the test method speahed In Annex A
3 SamplIng
Obtain a suffi.nt number ci lest speomens which are kf.n*cal to lb. rnarel.d product to complet. all lb. prescreed tests and any noeasary repeat teals
6 Test conditions and visual inspection
6.1 Test conditions
Prepare and last el sp.cirnerw ala temperalure ci (23±6) C.
6.2 Visual inspection
aj Use wausl .spection by normal acy withOut nagrtflcatico for delerm.r’i.g anpewiur sari q i Clause land Caeuee 8.
b) Use visual inspection with *10 magnification for deterrnming compliance with 4.t2
7 PackagIng
Th. packaging slid be audi that if will neither contaminate nor parme containiwbon of lb. integrated dental floss and handle.ISO 28158 pdf download.